Vol. 503 No. 5
4 Mr. R. Bruton asked the Minister for Health and Children if he has satisfied himself that the possible side effects from the taking of Roaccutane are clearly designated by label warnings; if he has further satisfied himself that the Irish Medicines Board has been furnished by the manufacturers (details supplied) of the drug with all the necessary information to assess its possible dangerous side effects. [10072/99]
As the Deputy will be aware from a number of questions I have answered in the House about this drug in the past, the Irish Medicines Board, which has statutory responsibility in this area, carried out a full review of the safety and efficacy of this product as part of the assessment of the renewal of the product authorisation in 1998 and as a result of new safety information regarding the development of neuropsychiatric reactions, including depression, suicide and suicide ideation.
As a result of this review, the board required that the summary of product characteristics in relation to the product be amended to reflect the new information which had become available. In particular, the revised warnings approved by the board for inclusion in the prescribing data and patient information leaflets included the following:
Special Warnings and Special Precautions for Use:
Roaccutane may cause depression, psychotic symptoms and rarely suicide attempts and suicide. Discontinuance of Roaccutane may be insufficient and further evaluation may be necessary. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Undesirable Effects:
Depression, psychotic symptoms and rarely suicide have been reported with Roaccutane.
A letter, approved by the board, drawing attention to the possible development of depression and suicide was issued by the company to physicians in May 1998. In addition, the Irish Medicines Board drug safety newsletter of September 1998, which is distributed to doctors, dentists and pharmacists, also contained details of the revised warnings.
I would stress that it is a condition of the product authorisation that availability of this drug is subject to its prescription and monitoring of its use by a consultant dermatologist. While I would emphasise to patients that they should read carefully the patient information leaflet supplied with the drug and consult with their physicians concerning any problems or difficulties that may arise in the course of its use, there is also a responsibility on physicians prescribing the drug to ensure that their patients are fully advised as to the possible side effects.
With regard to the second part of the question, there is a legal responsibility on the company, as a condition of its product authorisation, that it keep a record of reports of adverse effects associated with the use of the product and that it furnish the board with copies of any such reports of which it has a record or of which it is aware. A further condition of the authorisation requires that the company should inform the board of any information received by it which might alter the validity of the data provided in support of the authorisation or which would further the understanding of the substance or its effects or may alter the directions for the use of the product.
I am advised by the Irish Medicines Board that it currently understands that all information on Roaccutane, required under the conditions applicable to its product authorisation, has been made available to the board by the company. At the same time, the board has had ongoing discussions with the company regarding its pharmacovigilance responsibilities, i.e. the monitoring and reporting of adverse reactions, and it is continuing to monitor the functioning of the company's pharmacovigilance unit.
I want to stress that the board continues to monitor the safety of the use of Roaccutane and, to this end, it has asked the company to undertake a surveillance programme to monitor the use of the product in Ireland. Details of this surveillance programme are currently being finalised between the board and the company. The board is also aware of ongoing epidemiological research into the safety of Roaccutane. The results of these programmes and studies will be fully evaluated when available and the board, in line with its statutory responsibilities, will take whatever action may be deemed necessary in relation to this product.
Why was this issue not picked up earlier in respect of this drug, which presumably had previous approvals by the medicines board? How did this new information come to light about the potential side effects, which were not known to the board at an earlier stage? Does that suggest to the Minister that this drug is perhaps not sufficiently well established in the marketplace to be so readily available?
The Irish Medicines Board conducted a full review of the efficacy and safety of this product, as it would other products in the normal course. Revised warnings were approved by the board for inclusion in the prescribing data, as I outlined, as a result of that review. I presume that relates to the product itself and what, if any, adverse reactions and symptoms were emanating from its use. As the regulatory body, and this product is available in other jurisdictions—
The Minister will be aware there have been suggestions that there should be an inquiry into how the product did not have these warnings attached to it at an earlier stage in its development. Has the Minister any information from the board on how these side effects only became known late in the day? Can the public be satisfied that everything was done with the best probity on all sides?
The Irish Medicines Board is very much aware of the situation and has taken all prudent steps to inform the public about the product, which is a vitamin A derivative used in the treatment of acne. It is authorised by the Irish Medicines Board for the treatment of severe acne unresponsive to other treatments. Its availability is limited, in that it must be prescribed and its use monitored by a specialist dermatologist. My reply also points out that physicians have the responsibility to inform patients of any possible side effects that might occur.
It is also clear from my reply that the Irish Medicines Board, as the regulatory authority, is satisfied that the requirements and the conditions of the product authorisation are being met by the manufacturer. Having said that, it is conducting a surveillance programme, the results of which are being finalised at present. It appears to me, on the face of it, that the Irish Medicines Board is meeting its statutory responsibilities in this matter and seeking to point out the specific circumstances in which this product is available and the conditions under which it should be prescribed and used.
